Fake medicine

Caveat emptor means “buyer beware.” Fake medicines are now a multibillion-dollar industry affecting people in virtually every country in the world, and the problem is getting worse. It has been estimated that up to 15 percent of drugs sold worldwide are counterfeit, and in parts of Africa and Asia it can surpass 50 percent. We are also vulnerable in the United States even though we have a better-regulated pharmaceutical system.

This problem became epidemic in the late 1990s with the globalization of pharmaceutical manufacturing, the commercialization of the Internet and the relatively new drug Viagra. By 2002, hundreds of thousands of fake Viagra pills flooded the market, and today birth control pills, hormone replacements, diabetes treatments, weight-loss aids, cancer and transplant drugs, schizophrenia medicines and HIV therapies have all been counterfeited. The list goes on. The selling occurs mostly through online pharmacies worldwide, but the manufacturing appears to focus mainly in loosely regulated countries like China and India. Unfortunately, medications that come in injectable forms, like insulin, are even easier to counterfeit than tablets. One can just use sterile water or even tap water.

To create an online pharmacy is rather simple. Get the active pharmaceutical ingredients from China, put together a Web page, and you are ready to go. It literally could take 45 minutes to create your own.

Accountability for these “pharmacies” is virtually nonexistent. Of 10,000 Internet drug outlets surveyed by the National Association of Boards of Pharmacy, 97 percent were out of compliance with legal or patient safety standards.

Historically, drug smugglers are often penalized by way of imprisonment if the drugs in question are heroin or cocaine. But those who produce or smuggle counterfeit medicines, by contrast, often face lax enforcement and light punishment. Some governments look at drug counterfeiting as a trivial offense. After all, everybody likes cheap “Viagra.” Recently, the pharmaceutical industry has persuaded several governments to stiffen regulations against fake drugs because counterfeit drugs can kill. Most are poorly made, containing the wrong dose of the active ingredient or a totally different ingredient, such as antifreeze or arsenic. Drug resistance against bacteria can occur because of ineffective antibacterial medications, particularly in Africa and Southeast Asia; it is estimated that up to 30 percent are fakes. The United Nations estimates that roughly half of the antimalarial drugs sold in Africa are counterfeits. The World Health Organization estimates that at least 100,000 people per year, mostly in poor countries, are killed as a result of fake medicines. It is estimated that the global market for fake medicines could be worth over $200 billion per year.

Although the United States has the Food and Drug Administration (FDA) to watch over us, according to the commissioner at this organization, 80 percent of the ingredient manufacturing sites for FDA-approved drugs sit outside our country — located in one of the 300,000 facilities in 150 different countries. These small companies export FDA-regulated products into the United States. Clearly, there are many weak points along this odyssey from which to steal or introduce adulterated and counterfeit products. You may recall that in 2007, 149 people died as a result of contaminated Heparin.

There have been some recent reports suggesting that terrorist organizations in the Middle East are using fake medicine to fund their heinous activities against Israel.

The Rise of Counterfeit Cancer Medication

The counterfeiters have recently moved from fake Viagra to making counterfeit cancer drugs, probably because of the larger profits. These illegal manufacturers have become more aggressive, as a vial of the cancer drug Avastin sells for $2,400 compared to $10 to $20 a tablet for Viagra. Although speculative, I also believe these very immoral thieves feel that the patients with cancer will probably die anyway, so no one can prove the fake drugs were causative.

The United States traced some of these drugs that originated from China, which then passed to Turkey through England, and then were transported to our country. These fakes contained starch, salt, cleaning solvents and other chemicals, but not the active ingredient, according to Roche, Avastin’s manufacturer. Bogus copies of the breast-cancer drug Tamoxifen also have entered our shores in recent months.

In China, the manufacturers are licensed as chemical companies, therefore they are not subject to regulation or inspection, as in our country. It is rare that anyone is arrested or convicted for these heinous crimes against humanity.

Where Do We Go From Here?

Over the past 10 years, there have been some collaborations between national and international public health agencies, such as the FDA and the World Health Organization. Many counterfeit and illicit drugs have been confiscated, resulting in the arrest of more than 80 people, as well as the elimination of more than 18,000 illegal online pharmacies. The pharmaceutical manufacturers and the FDA are developing new anti-counterfeiting techniques, such as handheld counterfeit detection devices designed to analyze chemicals and potential tampering of these medicines. Also, some pharmaceutical companies have put identifying markers on drug packaging, which can be scanned, somewhat like radio-frequency identification. Some are more covert, using UV fibers woven into the packaging, inks and images. More recently, nanotechnological markers in DNA are being incorporated into the makeup of the drugs themselves to help prevent drug counterfeiting processes.

Unfortunately, these new technologies, to detect counterfeiting, do not eliminate the problem, but only minimize it. The FDA has recently discovered that counterfeiters target some consumers through social media platforms like Facebook and Twitter.

On an optimistic note, the government of Nigeria, where fake drugs are prevalent, has declared its intention to adopt a “war” against the counterfeiters. The Pharmaceutical Security Institute gives warning that this war will be hard to win. Hopefully, more obstacles developed by each country will raise the cost and complexity of manufacturing counterfeit drugs, thus the profit margin will diminish. Hopefully the “bad guys” may now choose to fake other objects instead of medication that cannot harm or kill anyone.

Dr. Norman Lavin is a clinical professor of endocrinology and director of endocrinology education at UCLA Medical School. He writes the Jewish Diseases blog at